BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVEA VENTILATOR

    MDR report key: 9275987 · Received November 4, 2019

    Report

    Report Number
    2021710-2019-10986
    Event Type
    Malfunction
    Date Received
    November 4, 2019
    Date of Event
    October 8, 2019
    Report Date
    October 8, 2019
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    PMA / PMN Number
    K103211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AT THIS TIME, VYAIRE HAS NOT RECEIVED THE SUSPECT DEVICE/COMPONENT FOR EVALUATION. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO VYAIRE THAT THE AVEA VENTILATOR INTERMITTENTLY WILL DISPLAY THE "CIRCUIT DISCONNECT" ALARM AND ALERT. THE CUSTOMER STATED THEY CHECKED THE TRANSDUCERS AND HAD JUST CALIBRATED ALL. THE VENTILATOR PASSED EST TESTING. WHEN IT WAS PUT INTO NORMAL OPERATION MODE THE UNIT STARTED DISPLAYING "CIRCUIT DISCONNECT" AND "LOW VE", AFTER A MINUTE THE "LOW VE" WENT AWAY. CUSTOMER STATED HE WAS GOING TO TRY A NEW KNOWN GOOD SENSOR AND GET BACK TO US. THE CUSTOMER ADVISED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1068786 AVEA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL AVEA

    Patients

    Seq Age Sex Outcome Treatment
    1